The Medicare Modernization Act of 2003 (MMA) contains several provisions concerning quality of care for beneficiaries under the Act’s forthcoming prescription drug benefit.  The provisions address: 

Under the prescription drug plan provisions of the MMA, PDP sponsors must develop quality assurance measures and systems to reduce medication errors and adverse drug interactions and to improve medication use. This is part of a set of prescription drug plan requirements that includes developing cost and utilization management and medication management programs, either directly or under contract, for drugs to be covered under the new Medicare Part D program.  According to the proposed regulations of August 3, 2004, the requirements apply to both stand-alone Prescription Drug Plans (PDPs) and to Medicare Advantage Plans that offer a prescription drug plan (MA-PDs).  A PDP or MA-PD sponsor, in meeting its obligations under these provisions, is free to utilize cost management tools (including differential payments).

Under the MMA, MA-PD and PDP sponsors must also provide beneficiaries with comparative information about their prescription drug plans, including the benefits provided, the monthly benefit premium, beneficiary cost-sharing responsibilities, quality and performance requirements, and the results of consumer satisfaction surveys regarding PDPs and MA-PDs.  The consumer satisfaction information must be gathered and reported in a fashion similar to the requirements set for consumer satisfaction surveys conducted by Medicare Advantage organizations under Medicare Part C.  Importantly, however, prescription drug plans do not have to provide information on quality of performance and consumer satisfaction surveys for the first year in which the plan is offered, nor for the next plan year, if it is impracticable to do so or if the information is otherwise unavailable.

Under the proposed regulations to implement the prescription drug benefit, a PDP or MA-PD plan must disclose required information, including information about its quality assurance program. The quality assurance program must include measures and systems to reduce medication errors and adverse drug interactions and to improve medication use.  In doing so, the program is to establish a process for drug utilization review, patient counseling, and patient information record-keeping.

Under contracts with the Secretary of HHS, Quality Improvement Organizations (QIOs) are to offer providers, practitioners, MA organizations, and PDP sponsors quality improvement assistance pertaining to health care services, including those related to prescription drug therapy.  It should be noted, however, that the proposed QIO responsibilities do not include the review of beneficiary disputes about services or quality of services. Rather, the emphasis is on offering providers, practitioners, MA organizations, and PDP sponsors assistance in obtaining and maintaining compliance with the quality assurance requirements of reducing medication errors and adverse drug interactions and to improving medication use.

The proposed regulations provide that a PDP or MA-PD is deemed to meet all of the requirements of the proposed regulation if it is fully accredited (and periodically reaccredited) by a private, national accreditation organization approved by the Centers for Medicare & Medicaid Services (CMS), and the accrediting organization uses standards approved by CMS. 

These “deemable” requirements include the cost and utilization management, quality assurance, and medication management programs.  In addition, PDPs and MA-PDs must submit to surveys by CMS to validate its accreditation organization’s accreditation process, and must authorize its accreditation organization to release to CMS a copy of its most recent accreditation survey, together with any survey-related information that CMS may require (including corrective action plans and summaries of unmet CMS requirements). 

CMS proposes to retain its enforcement authority to initiate enforcement action against any PDP or MA-PD where CMS determines, on the basis of its own surveys or the results of an accreditation survey, that a PDP or MA-PD no longer meets the Medicare requirements for which deemed status was granted.

Quality of care, as a health care focus, is an essential element of access to health care services.  For more information about the importance of “quality of care,” please see the Quality of Care section of the Center for Medicare Advocacy’s website,  For citations, or additional information regarding quality of care, please contact Alfred Chiplin in the Center for Medicare Advocacy’s Washington, DC office, at (202) 293-5760 or

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